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Antimicrobial Efficacy Consultant

3 months ago

Columbia City, United States Scientific & Regulatory Consultants, Inc. Full time

Join the SRC family


We are seeking an experienced professional for this fully remote position to assist clients in placing and managing antimicrobial and pesticide product efficacy testing to achieve EPA and FDA regulatory compliance. Actual job title and compensation based on relevant experience.


Essential Functions and Responsibilities:

• Place and manage FDA/EPA/Health Canada/International Good Laboratory Practices (GLP) and non-GLP efficacy

studies

• Develop testing strategies unique to each client

• Evaluate client needs and provide regulatory solutions to meet product sales and marketing goals

• Design antimicrobial test methods and new protocol review for EPA/FDA/Health Canada submissions

• Review efficacy protocols and reports for compliance with applicable regulations for EPA/FDA/Health Canada

• Develop and maintain lasting relationships with clients, laboratories, state, and federal government regulators

Interact and negotiate with government agencies and laboratories on behalf of SRC and clients

• Source new test strains and labs globally, as needed

• Assist clients with research and development of novel products, claims, and uses

• Assist clients in filing Adverse Events or responding to Agency inquiries/enforcement actions

• Recognize and initiate workplace process improvements, inclusion, and project management

• Process client study files and ensure quality assurance measures are in place according to Good Laboratory

Practices

• Assist with developing educational blogs and marketing pieces (trade show events, website, blogs, speaking

engagements, etc.)

• Manages specialized projects and functions within the Efficacy Team or other departments as assigned

• Follow national and international regulatory issues; communicate trends, potential challenges, or opportunities to

management with proposed solutions

• Showcase workflow efficiencies and demonstrate organization and time management skills

• Work in a team-focused environment to achieve team and client goals and deadlines

• Participate in business development and sales activities by selling registration services to new and existing clients

• Provide internal and external training

• Create and review SOPs and validation documentation

• Maintain electronic filing, tracking systems, and data entry

• Perform research using FOIA, Knowtify, PUBMED and other applicable search engines/resources

• Perform client and lab audits

• Present/moderate at trade association meetings

• Participate in industry trade associations and volunteer for leadership roles Effectively communicate with clients,

supervisors, and co-workers by telephone, e-mail, written form, in person, and digital platforms

• Travel – 0 to 1 overnight trips/month

• Additional duties as assigned by Manager


Qualifications:

• Bachelor’s Degree

• 5+ years, or equivalent/related, experience in FIFRA efficacy testing or related areas

• Effective communicator

• Organization and time management skills

• Ability to work independently and/or with internal and external team members

• Innovative problem solver

• Must be able to work under pressure and meet deadlines

• Able to handle sensitive and confidential situations with tact and diplomacy

• Proficient in Office365 applications (Word, Excel, PowerPoint, and Outlook)

• Positive attitude and proactive approach to work


Preferred:

• EPA FIFRA experience

• Previous experience with government regulatory agencies

• Knowledge of:

o EPA/FDA/OECD Good Laboratory Practices

o EPA/California DPR/Health Canada regulations and standards

o AOAC, ISO, OECD, EN, EPA, and ASTM methods

o Antimicrobial efficacy testing for EPA/FDA/Health Canada

• Aptitude for customer service

• Project management experience


Requirements:

• Comprehend, retain, and follow verbal and written instructions

• Exercise independent judgment and make sound decisions

• Perform in situations requiring attention to detail, speed, deadline management, and efficiency

• Able to manage multiple projects simultaneously

• Complete assigned tasks and maintain deadlines with little to no supervision

• Clearly articulate information (oral and written) to diverse groups of people

• Perform essential functions safely and successfully

• Maintain regular, punctual attendance whether remotely or on-site

• Must be able to complete job responsibilities utilizing a computer and remain in a stationary position (standing and/or

sitting) at desk for 8 hours per workday